FDA 510(k)

经皮神经电刺激（TENS）设备-HeadaTerm 2（型号：YF-HT2）

K号: K230782 · 2024-02-26

决定日期2024-02-26

产品代码PCC

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决定实质等同

器械摘要

TENS device-HeadaTerm 2 (Model: YF-HT2) is the device name listed in this FDA 510(k) record. The listed applicant is Wat Medical Technology, Inc.. It received FDA 510(k) clearance on 2024-02-26 under 510(k) number K230782. The device is classified under product code PCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TENS device-HeadaTerm 2 (Model: YF-HT2)?

TENS device-HeadaTerm 2 (Model: YF-HT2) is a medical device that received FDA 510(k) clearance on 2024-02-26. The listed applicant is Wat Medical Technology, Inc.. The 510(k) number is K230782.

When did TENS device-HeadaTerm 2 (Model: YF-HT2) receive FDA 510(k) clearance?

TENS device-HeadaTerm 2 (Model: YF-HT2) received FDA 510(k) clearance on 2024-02-26, under 510(k) number K230782.

Who is the listed applicant for TENS device-HeadaTerm 2 (Model: YF-HT2)?

The FDA 510(k) record lists Wat Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS device-HeadaTerm 2 (Model: YF-HT2)?

The FDA product code for TENS device-HeadaTerm 2 (Model: YF-HT2) is PCC.

列明Wat Medical Technology, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K220503经皮神经电刺激（TENS）设备-EmeTerm 2，型号：YF-ZTY-E2

官方来源

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